FDA applicant
Bio-Dyne, Inc.
FDA records 3 decisions for Bio-Dyne, Inc. (La Mesa, CA) from 1987 to 1990: 3 510(k) clearances. Most are in product codes GEC (Brush, Scrub, Operating-Room) and BZQ (Monitor, Breathing Frequency). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Bio-Dyne, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Bio-Dyne, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Bio-Dyne, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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